Drip chamber with luer fitting

ABSTRACT

A drip chamber has an open distal end and a luer fitting is positioned in the open distal end of the drip chamber to engage a complementary fitting associated with another IV component, e.g., an IV fluid bag. Thus, the drip chamber can be engaged with an IV bag without the use of &#34;sharps&#34;.

This application is a continuation of application Ser. No. 08/377,514,filed Jan. 24, 1995 now abandoned, which is a divisional of priorapplication Ser. No. 08/098,499, filed Jul. 28, 1993, now U.S. Pat. No.5,445,623.

FIELD OF THE INVENTION

The present invention relates generally to IV set components, and moreparticularly to drip chambers and IV set valves.

BACKGROUND

One of the most widely used methods of medical therapy is theintravenous (IV) infusion of liquid medicaments and/or nutrients intothe bloodstream of a patient. A familiar apparatus that is used in manyIV infusion applications is an IV container, such as an IV bag orbottle, which contains the liquid to be infused into the patient.

When the IV container is a bag, a rigid, hollow, sharpened IV spike ispushed into the bag to establish a pathway for fluid communicationthrough which the liquid can flow out of the bag. The spike, in turn, isconnected to or formed integrally with an inlet port of a small,elongated, transparent hollow container familiarly referred to as a"drip chamber", with the fluid pathway of the spike in fluidcommunication with the inlet port of the drip chamber.

Additionally, an IV line is connected to an outlet port (which islocated below the inlet port) of the drip chamber. Preferably, a rollerclamp (or other suitable flow regulating device) is engaged with the IVline, and a medical technician can manipulate the roller clamp tosqueeze the IV line and thereby regulate fluid flow through the IV line.To establish a path for fluid communication from the IV bag or bottle tothe patient, a sharp needle is connected to the IV line to puncture thepatient.

Usually, the bag or bottle is elevated above the patient to establish apositive pressure head to force the fluid that is within the bag orbottle through the drip chamber into the patient. Because the dripchamber is transparent, a medical technician can view the medicament asit passes (normally by dripping) through the drip chamber to aid themedical technician in establishing a predetermined flow rate ofmedicament into the patient as the medical technician adjusts the rollerclamp on the IV line.

While effective as aids in establishing a predetermined fluid flowthrough the patient, existing drip chambers, as noted above, require theuse of sharpened spikes to puncture the IV bag or bottle containing theliquid. This is undesirable, particularly in the era of AIDS, becausespikes, like other sharps instruments, can inadvertently puncture themedical technician who is manipulating the spike and thereby potentiallyinfect the technician with AIDS or other disease. Thus, as recognized bythe present invention, it is desirable to avoid the use of sharpinstruments whenever possible.

Further, it is desirable to connect and disconnect IV lines to the dripchamber without spillage of medicament. As recognized by the presentinvention, such reduction in spillage can be obtained through the use ofreflex valves which are compatible with needleless drip chambers andother needleless IV components.

Accordingly, it is an object of the present invention to provide a dripchamber which does not require the use of "sharps" in infusing orextract fluid from the bag. Another object of the present invention toprovide a drip chamber which is easy to use and cost-effective tomanufacture. A further object of the present invention is to provide avalve apparatus in an IV drip chamber or other IV component for engaginga complementary fitting, without the need to use a sharp connector.

SUMMARY OF THE INVENTION

A drip chamber includes a container defining a hollow chamber, and thecontainer has a proximal end and a distal end. Preferably, the proximalend of the container is engageable with an intravenous (IV) tube toestablish a pathway for fluid communication between the IV tube and thechamber of the container. A fitting is attached to the container nearthe distal end of the container, and the fitting includes an annularelement which has a dull distal end and a passageway in fluidcommunication with the chamber. As intended by the present invention,the element is positioned with the dull distal end of the elementprotruding away from the open distal end of the container.

In the presently preferred embodiment, the element is a male element,preferably a male luer fitting, and the drip chamber further includes anannular cap engaged with the male element in a surrounding relationshiptherewith. The cap has a threaded inner surface which faces the maleelement and which is spaced from the male element for threadablyengaging a complementarily threaded surface.

If desired, the cap can be rotatably engaged with the male element. Inthis embodiment, the male element is formed with a collar and the cap isformed with a flange protruding inwardly from the threaded inner surfaceof the cap for abutting the collar and preventing the flange from movingdistally past the collar. Furthermore, the flange of the cap has atleast one opening formed therein, and the collar of the male element hasa tapered surface for permitting the collar to move distally through theopening of the flange. Accordingly, the collar is substantiallyprevented from moving proximally through the opening. Alternatively, thecap can be fixedly attached to the male element.

To hold the fitting onto the container, the fitting includes a sleeveattached to the male element and engageable with the container.

In another embodiment, a valve is disposed in the passageway of thefitting to selectively permit fluid communication through thepassageway. The valve has a closed configuration and an openconfiguration, and the valve is biased to the closed configuration andis moved to the open configuration when the fitting is operably engagedwith a complementary fitting.

In accordance with the present invention, the valve includes a hollowbody which defines a fluid passageway therethrough. A resilient valvedisc is positioned in the fluid passageway of the body and is biasedinto a closed configuration, wherein the disc blocks fluid flow throughthe fluid passageway. Also, the disc is movable to an openconfiguration, wherein fluid flow is permitted through the fluidpassageway.

Moreover, the valve includes a support element positioned on the valvebody for supporting the valve disc at the center of the disc, and atleast one protrusion is formed on the body for contacting the disc inthe open configuration. Also, a retainer element is positioned in thevalve on the opposite side of the disc from the support element, to holdthe center of the disc against the support element. Importantly, a valveelement is reciprocally disposed in the fluid passageway of the valve onthe same side of the disc as the retainer element. The valve element ismovable between a first position, wherein the valve element is distancedfrom the valve disc and at least a portion of the valve elementprotrudes distally beyond the dull distal end of the male element of thefitting, and a second position, wherein the valve element contacts thevalve disc to move the disc into its open configuration, wherein thevalve element is moved to its second position when the fitting isengaged with a complementary fitting.

In another aspect of the present invention, a device is disclosed forpermitting visual monitoring of fluid flow from a fluid source having aluer fitting to an intravenous (IV) tube. The device includes a hollowtransparent drip chamber which is engageable with the IV tube, and aluer fitting that is attached to the drip chamber and which isengageable with the luer fitting of the fluid source.

In yet another aspect of the present invention, a method is disclosedfor establishing fluid communication between an intravenous (IV) tubeand a fluid source having a fitting. The method of the present inventionincludes the steps of providing a drip chamber, and attaching a luerfitting to the drip chamber. Then, the drip chamber is engaged with theIV tube. Next, the luer fitting is engaged with the fitting of the fluidsource, to thereby establish fluid communication between the fluidsource and the IV tube.

In still another aspect of the present invention, a valve has a closedconfiguration and an open configuration, wherein the valve is biased tothe closed configuration and is movable to the open configuration. Thevalve of the present invention includes a hollow body that defines afluid passageway, and a resilient valve disc which is positioned in thefluid passageway of the body.

The valve disc is biased into a closed configuration, wherein the discblocks fluid flow through the fluid passageway. Also, the disc ismovable to an open configuration, wherein fluid flow is permittedthrough the fluid passageway.

A support element is positioned on the valve body for supporting thevalve disc at the center of the disc, and at least one protrusion isformed on the body for contacting the disc in the open configuration. Aretainer element is positioned in the valve on the opposite side of thedisc from the support element, to hold the center of the disc againstthe support element, and a valve element is reciprocally disposed in thefluid passageway of the valve on the same side of the disc as theretainer element.

The valve element is movable between a first position, wherein the valveelement is distanced from the valve disc and protrudes distally beyondthe valve body, and a second position, wherein the valve elementcontacts the valve disc to move the disc into its open configuration. Asintended by the present invention, the valve element includes acylindrical outer surface and an engagement member protruding radiallyoutwardly from the cylindrical outer surface for contacting an interiorsurface of a female luer fitting to move the valve element to its secondposition.

The details of the present invention, both as to its construction andoperation, can best be understood in reference to the accompanyingdrawings, in which like numerals refer to like parts, and which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the drip chamber of the presentinvention, shown in an exploded relationship with an IV bag;

FIG. 2 is a cross-sectional view of the drip chamber shown in FIG. 1, asseen along the line 2--2 in FIG. 1;

FIG. 3 is a cross-sectional view of an alternate embodiment of the dripchamber of the present invention, as would be seen along the line 2--2in FIG. 1, with portions cut away;

FIG. 4 is a cross-sectional view of another alternate embodiment of thedrip chamber of the present invention, as would be seen along the line2--2 in FIG. 1, with portions cut away;

FIG. 5 is a perspective view of still another alternate embodiment ofthe drip chamber of the present invention, with a flow restrictor shownin phantom;

FIG. 6 is a cross-sectional view of the drip chamber shown in FIG. 5, asseen along the line 6--6 in FIG. 5, with portions cut away;

FIG. 7 is an exploded view of yet another alternate embodiment of thedrip chamber of the present invention having a reflex valve;

FIG. 8 is a cross-sectional view of the drip chamber embodiment shown inFIG. 7, with the components of the drip chamber shown in their operativerelationships and the valve in the closed configuration, with portionscut away;

FIG. 9 is a cross-sectional view of the drip chamber embodiment shown inFIG. 7, with the components of the drip chamber shown in their operativerelationships and the valve in the open configuration, with portions cutaway;

FIG. 10 is a cross-sectional view of an alternate embodiment of the dripchamber with reflex valve, showing a female luer fitting, with portionscut away for clarity, with portions cut away;

FIG. 10A is a view substantially like that of FIG. 10, but showinggrooves in place of protrusions.

FIG. 11 is a cross-sectional view of still another alternate embodimentof the drip chamber with reflex valve, showing a vented configuration ofthe drip chamber, with portions cut away for clarity;

FIG. 12 is a cross-sectional view of another alternate embodiment of thereflex valve of the present invention, shown in a male-female adaptorconfiguration, with portions cut away; and

FIG. 13 is a cross-sectional view of a bag fitting of an alternateembodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to FIG. 1, a needleless plastic drip chamber isshown, generally designated 10. Preferably, the drip chamber 10 is madeof polypropylene or polyethylene. As shown, the drip chamber 10 has adistal end 12 which can be operably engaged with a source 14 of fluid,such as the IV bag shown, and the IV bag can in turn be suspended froman IV pole 15. It is to be understood that the source 14 of fluid can beany container suitable for holding fluid medicaments, e.g., the source14 can be an intravenous (IV) bag, vial, or bottle.

As further shown in FIG. 1, the drip chamber 10 has a proximal end 16that can be engaged with an IV tube 18. Specifically, the IV tube 18 isadvanced into the proximal end 16 of the drip chamber 10 and is held inthe proximal end 16 by solvent bonding, rf sealing, or ultrasonicwelding techniques.

Now referring to FIG. 2, the drip chamber 10 includes a hollowtransparent glass or plastic container 20, and the container 20 definesa hollow chamber 22. As shown, the container 20 has an open distal end24, and a needleless fitting, generally designated 26, is attached tothe container 20 near the open distal end 24 of the container 20. In theembodiment shown, the fitting 26 is a male luer fitting for engaging acomplementarily shaped female luer fitting 14a on the source 14 of fluid(FIG. 1).

More particularly, the fitting 26 includes an annular male element 28that has a dull, i.e., non-sharp or blunt, distal end 30 and apassageway 32 in fluid communication with the chamber 22. As shown inFIG. 2, the male element 28 is positioned coaxially with the container20, with the dull distal end 30 of the element 28 protruding away fromthe open distal end 24 of the container 20.

In further reference to FIG. 2, the male element 28 has an outsidesurface 34 which is frusto-conical in shape and an inside surface 36which is cylindrical in shape. In other words, the outside surface 34 isslightly tapered radially inwardly toward the distal end 30 of the maleelement 28. A male luer locking ring 37 having a threaded surface 37aspaced from the male element 28 and facing the male element 28 is formedintegrally with the male element 28 for threadably engaging the femaleluer fitting 14a (FIG. 1).

FIG. 3 shows an alternate embodiment of the drip chamber of the presentinvention, generally designated 38, which is in all essential respectsidentical to the drip chamber 10, except that the drip chamber 38 has nomale luer locking ring.

FIG. 4 shows another alternate embodiment of the drip chamber of thepresent invention, generally designated 40, which is in all essentialrespects identical to the drip chamber 10, except that the drip chamber40 has a needleless fitting 42 configured as a female luer fitting. Suchan embodiment is used to engage a male luer fitting on a source of fluid(not shown). Accordingly, the female luer fitting 42 has afrusto-conical inside surface 44 which is slightly radially taperedoutwardly toward a distal end 46 of the fitting 42, a cylindricaloutside surface 48, and luer ears 50 formed near the distal end 46 whichproject radially outwardly from the outside surface 48 for engaging amale luer fitting (not shown in FIG. 4).

FIGS. 5 and 6 show yet another alternate embodiment of the drip chamberof the present invention, generally designated 52. As shown, the dripchamber 52 has a fitting 54 having a male element 56 and a cap 58rotatably engaged with the male element 56, and the cap 58 is formedwith a threaded inner surface 60. Thus, the fitting 54 is configured asa male luer fitting. It is to be understood that the fitting 54 can beused in place of the fittings 26, 42 described above on the dripchambers 10, 40.

As best shown in FIG. 6, the male element 56 is formed with two or morecollar elements 62a, 62b. As shown, each collar element 62a, 62b has arespective tapered surface 64a, 64b and a respective flat surface 66a,66b. Each flat surface has a length L measured from the longitudinalaxis of the male element 28 to the tip of the respective collar element62a, 62b.

FIGS. 5 and 6 show that the annular, generally cylindrical cap 58 isrotatably engaged with the male element 56 in a surrounding relationshipwith the element 56, and the cap 58 is substantially coaxial with themale element 56. Importantly, the threaded inner surface 60 of the cap58 faces the male element 56 and is spaced from the element 56 forthreadably engaging a complementarily threaded surface of a female luerfitting.

In the embodiment shown in FIGS. 5 and 6, the cap 58 is rotatablyengaged with the male element 56. In this embodiment, the cap 58 isformed with an annular flange 68 which protrudes inwardly from thethreaded inner surface 60 of the cap 58 for abutting the collar elements62a, 62b and preventing the flange 68 from moving distally past thecollar elements 62a, 62b.

As best shown in FIG. 6, the flange 68 of the cap 58 has at least one,and preferably six (6), openings 70 formed in it. It can be appreciatedin reference to FIG. 6 that the openings 70 are configured such that thecollar elements 62a, 62b can move distally through the openings 70, uponproper alignment of the collar elements 62a, 62b with the openings 70,while substantially preventing the collar elements 62a, 62b from movingproximally through the openings 70.

More specifically, each opening 70 has a length L' measured from thelongitudinal axis of the cap 58 to the respective end of the opening 70,and the lengths L' of the openings 70 are marginally less than thelengths L of the collar elements 62a, 62b. Consequently, the cap 58 canbe pushed proximally onto the male element 56, and when the taperedsurfaces 64a, 64b of the collar elements 62a, 62b are aligned withrespective openings 70, the collar elements 62a, 62b can be squeezedthrough respective openings 70. Distal motion of the flange 68 past thecollar elements 62a, 62b, however, is prevented because the flatsurfaces 66a, 66b of the collar elements 62a, 62b cannot easily passproximally through the openings 70. In other words, with the combinationof structure described herein, the cap 58 can be snapped onto the maleelement 56 to hold the cap 58 in rotatable engagement with the maleelement 56.

As further shown in FIG. 5, the fitting 54 includes a rigid hollowtubular sleeve 72, and the sleeve 72 is attached to the male element 56by solvent bonding, rf sealing, spin welding, or sonic welding.Alternatively, the sleeve 72 can be formed integrally with the maleelement 56. In either case, the sleeve 72 is engageable with a hollowdrip chamber container 74 to hold the fitting 54 onto the container 74,thereby establishing the drip chamber 52. Specifically, the sleeve 72can be solvent bonded to the container 74, or attached to the container74 by any suitable means well-known in the art.

More specifically, FIG. 5 shows that the sleeve 72 by a well-knownarrangement known as a four-way seal. With this arrangement, duringmanufacture, at least a portion 74a of the container 74 is heated, tomake it malleable, and then heat-sealed or rf-sealed around the sleeve72 of the fitting 54 at four points 76a, 76b, 76c, 76d to establish afluid tight seal between the sleeve 72 and the container 74 at thepoints 76a, 76b, 76c, 76d.

Additionally, FIG. 5 shows that a flow restrictor 78 can be positionedin the sleeve 72. The flow restrictor 78 has a tube 80 which has adiameter sized such that fluid passes through the tube 80 at apredetermined rate, e.g., sixty (60) drips per minute or twenty (20)drips per minute. A resilient engagement element 82 is closely receivedin the sleeve 72, and the element 82 is held within the sleeve 72 by anysuitable means well-known in the art, e.g. solvent bonding, rf sealing,or ultrasonic welding, to hold the flow restrictor 78 within the sleeve72.

It is to be appreciated from the disclosure above that the fittings 26,42, 54 are not sharp, i.e., they do not have any surfaces which caneasily puncture a human body.

Now referring to FIGS. 7, 8, and 9, an alternate embodiment of the dripchamber of the present invention is shown, generally designated 100. Thedrip chamber 100 has a fitting 102 which is in all essential respectsidentical to the fitting 26 shown in FIGS. 1 and 2, except that a malereflex valve, generally designated 104, is positioned in the fitting 102shown in FIGS. 7 and 8 for selectively permitting fluid communicationthrough the fitting 102.

As shown best in FIG. 8, in one presently preferred embodiment thefitting 102 includes a rigid, preferably plastic (e.g., PVC) valve body106 that has a fluid inlet 108, a fluid outlet 110, and a fluidpassageway 112 formed in the valve body 106 between the inlet 108 andoutlet 110. The valve body 106 can be a unitary structure, or be made oftwo or more pieces that are bonded together, as shown. For example, theinlet 108 can be formed from first pieces 114a, 114b, the outlet 110 canbe formed from a second piece 116, and the pieces 114a, 114b, 116 can bebonded together by means well-known in the art, e.g., solvent bonding,ultrasonic sealing, or rf welding.

The second piece 116 can advantageously be formed with an annular flange115 for providing a surface that can be manipulated to urge the fitting102 into a container 117, or to engage the drip chamber 100 with an IVinfusion pump (not shown). Then, a bonding collar 119 is bonded to thecontainer 117.

In cross-reference to FIGS. 7, 8, and 9, the reflex valve 104 alsoincludes a flexible resilient plastic or silicon rubber disc 118 that isdisposed in the fluid passageway 112. Specifically, the periphery of theplastic disc 118 rests on a seating surface 120 of the valve body 106 toestablish a fluid-tight seat between the disc 118 and seating surface120, when the disc 118 is in the closed configuration shown in FIG. 8.It is to be understood that the valve disc 118 is biased to the closedconfiguration shown in FIG. 8, wherein no fluid communication ispermitted through the valve 104 (and, hence, through the fitting 102).Cylindrical or pyramidal protrusions 106a are formed on the valve body106 for preventing a vacuum lock from being established between theprotrusions 106a and the valve disc 118. Alternatively, grooves 107shown in FIG. 10A can be formed on the valve body 106 for preventing avacuum lock from being established between the grooves 107 and the valvedisc 118.

FIG. 8 shows that a support element 122 is formed in the fluidpassageway 112 and extends across the fluid passageway 112. As shown,the support element 122 supports the disc 118 in the center thereof. Tothis end, a slight depression may be formed in the center of the disc118 to receive the support element 122 and thereby prevent side-to-sidemotion of the disc 118 relative to the support element 122. As furthershown, the support element 122 is shaped as a cylinder, but it is to beunderstood that the support element 122 can have other suitable shapes,e.g., the support element 122 can have a triangular shape.

Additionally, a retainer element 124 is formed on the valve body 106 andextends across the fluid passageway 112. As shown in FIG. 7, theretainer element 124 is positioned on the valve body 106 on the oppositeside of the valve disc 118 from the support element 122. Accordingly,the retainer element 124 holds the center of the valve disc 118 againstthe support element 122.

Still referring to FIGS. 7, 8, and 9, a hollow rigid valve element 126is shown slidably disposed in the fluid passageway 112 for reciprocalmovement therein. As shown, the valve element 126 has an engagementmember, preferably an annular head 128, and a skirt 130 that dependsfrom the head 128. As further shown, the skirt 130 includes a pluralityof, preferably two, legs, and has a cylindrical outer surface 132. FIG.8 best shows that when the disc 118 is in the closed configuration, thehead 128 of the valve element 126 protrudes distally beyond the fitting102.

In cross-reference to FIGS. 8 and 9, the head 128 of the valve element126 protrudes radially outwardly from the cylindrical outer surface 132of the skirt 130. Accordingly, as best shown in FIG. 9, the head 128 cancontact a tapered interior surface 134 of a hollow female luer fitting136 when the female luer fitting 136 is engaged with the male luerfitting 102. As the female luer fitting 136 is engaged with the maleluer fitting 102, the valve element 126 is moved against the valve disc118 to thereby deform the valve disc 118 into an open configuration, topermit fluid flow through the fluid passageway 112.

Stated differently, when the valve element 126 is forced against thevalve disc 118 by the female luer fitting 136, the skirt 130 of thevalve element 126 contacts the surface of the disc 118. This deforms thevalve disc 118, causing the sealing surface of the disc 118 to bedistanced from the seating surface 120 of the valve body 106, andthereby permitting fluid communication through the fluid passageway 112.

It is to be understood that when the female luer fitting 136 isdisengaged from the male luer fitting 102, the resiliency of the valvedisc 118 causes the disc 118 to resume its normally closedconfiguration, shown in FIG. 8.

Now referring to FIG. 10, a drip chamber generally designated 140 isshown which has a transparent hollow container 142 and a non-sharpfitting 144. As shown, the drip chamber 140 is substantially similar tothe drip chamber 100 shown in FIGS. 7-9, except that the fitting 144 ofthe drip chamber 140 shown in FIG. 9 is a female luer fitting. Also, thefitting 144 includes a valve element 146 which does not have anengagement surface which extends radially outwardly from a cylindricalskirt 148, in contrast to the valve element 126 shown in FIGS. 7-9.Instead, the valve element 146 has an engagement end 150 that isessentially a base of the cylindrical skirt 148. The end 150 is urgedtoward a valve disc 152 by a male luer fitting (not shown) duringengagement of the male luer fitting with the female luer fitting 144shown in FIG. 10.

FIG. 11 shows a vented drip chamber, generally designated 160. As shown,the drip chamber 160 has a male luer fitting 162 that is in allessential respects identical to the fitting 126 shown in FIGS. 7-9, andwhich is connected by means well-known in the art to a vent fitting 164.In turn, the vent fitting 164 is connected to a hollow transparentcontainer 166.

The purpose of the vent fitting 164 is to vent air from the container166. Accordingly, the vent fitting 164 has a gas fitting 167establishing a gas passageway 168 that is in fluid communication withthe interior of the container 166 via a fluid passageway 170 that isformed in the vent fitting 164.

A hydrophobic membrane 172 is positioned athwart the gas passageway 168,and a ball 174 is positioned for reciprocating movement within the gaspassageway 168. The ball 174 can contact a seat 176 that is formed inthe gas fitting 167 when no air is present in the container 166, toblock fluid flow through the gas passageway 168. On the other hand, gaswithin the container 166 will urge the ball 174 away from the seat 176to permit the gas to pass out of the container 166 through the fluidpassageway 170, gas passageway 168, and hydrophobic membrane 172.

Now referring to FIG. 12, a male-female reflex valve, generallydesignated 200, is shown. The valve 200 has a valve body 202establishing a male luer fitting 204, and a male valve element 206 ispositioned in the valve body 202. The valve body 202 is bonded to asupport piece 207. Alternatively, the body 202 can be attached to thesupport piece 207 by ultrasonic welding or rf sealing.

As shown in FIG. 12, the valve 200 is in all essential respectsidentical to the valve 104 shown in FIGS. 7-9, except that the valve 200shown in FIG. 12 is not positioned in a drip chamber fitting. Instead,the valve 200 can be used as a connector between two complementary luerfittings to selectively permit fluid communication through the valve200.

Accordingly, in contrast to the piece 116 of the valve 104 shown inFIGS. 7-9, a piece 208 of the valve 200 corresponding to the piece 116is configured as a female luer fitting 210, and is bonded to the supportpiece 207. Thus, it can be appreciated that the male luer fitting 204can be engaged with a female luer fitting (not shown) which isassociated with a first IV component, while the female luer fitting 210is engaged with a male luer fitting (not shown) which is associated witha second IV component. Additionally, if desired, a female valve element211 can be positioned within the female luer fitting 210, to selectivelyestablish fluid communication between the two components only when bothluer fittings are engaged with the valve 200.

If further desired, a tamper-resistant cap 212 can be engaged with thereflex valve 200. In one presently preferred embodiment, a skirt 214 ofthe cap 212 has a plurality of resilient ratchet threads 216. Theratchet threads 216 are configured generally as right triangles, asshown, and permit rotation of the cap 212 in the clockwise directionrelative to the reflex valve 200 to thereby engage the cap 212 with thereflex valve 200. The threads 216 do not, however, permit easy rotationof the cap 212 in the counter clockwise direction. The threads 216ratchetably engage blades 218 that are formed on the valve body 202. Itis to be understood that the cap 212 can engage any appropriate surfaceof the valve body 202.

As can be appreciated by the skilled artisan, to disengage the cap 212from the reflex valve 200, sufficient torque must be imparted to the cap212 to strip to ratchet threads 216. Consequently, once the cap 212 hasbeen removed from the reflex valve 200, it cannot be re-engaged with thereflex valve 200. Thus, a missing or stripped cap 212 indicates that thecap 212 has been tampered with. It is to be understood that if desired,a new cap (not shown) that is in all essential respects identical to thecap 212 can then be engaged with the reflex valve 200. If desired, thenew cap can have a color which is different from the color of the cap212.

FIG. 13 shows a needleless bag fitting 230 that can be bonded to thevalve body 202 shown in FIG. 12 in place of the support piece 207 andfemale luer fitting 210. As shown, the bag fitting 230 has a flatsurface 232 which can be bonded to the surface of a fluid container,e.g., an IV bag (not shown) in a so-called bellybutton arrangement. Ifdesired, a protrusion 234 can be formed on the flat surface 232, and theprotrusion 234 extends away from the surface 232. The protrusion 234 canaccordingly urge aside a perforated portion of the IV bag to establish apath for fluid communication from the bag to the bag fitting 230. Also,the bag fitting 230 can have grooves 236 formed thereon to functionanalogously to the protrusions 106a shown in FIGS. 7-9, i.e., to preventa vacuum lock from being established between the grooves 236 and a valvedisc similar to the disc 118 shown in FIGS. 7-9.

While the particular drip chamber as herein shown and described indetail is fully capable of attaining the above-described objects of theinvention, it is to be understood that it is the presently preferredembodiment of the present invention and is thus representative of thesubject matter which is broadly contemplated by the present invention,that the scope of the present invention fully encompasses otherembodiments which may become obvious to those skilled in the art, andthat the scope of the present invention is accordingly to be limited bynothing other than the appended claims.

What is claimed is:
 1. A device for permitting visual monitoring offluid flow from a fluid source having a luer fitting to an intravenous(IV) tube, comprising:a hollow elongated transparent drip chamber havinga proximal end engageable with the IV tube, the drip chamber also havinga distal end and a drip-forming tube positioned therebetween; a femaleluer fitting attached to the distal end of the drip chamber andengageable with the luer fitting of the fluid source, wherein fluid fromthe fluid source flows through the drip chamber from the distal end ofthe drip chamber to the proximal end of the drip chamber, the luerfitting establishing a fluid passageway; and a valve disposed in thepassageway of the luer fitting to selectively permit fluid communicationthrough the passageway, the valve having a closed configuration and anopen configuration, the valve being biased to the closed configurationand movable to the open configuration when the luer fitting of thedevice is operably engaged with the luer fitting of the fluid source. 2.The device of claim 1, wherein the valve includes:a hollow body defininga fluid passageway therethrough; and a resilient valve disc positionedin the fluid passageway of the body and being biased into a closedconfiguration, wherein the disc blocks fluid flow through the fluidpassageway, the disc being movable to an open configuration, whereinfluid flow is permitted through the fluid passageway.
 3. The device ofclaim 2, wherein the valve further comprises:a support elementpositioned on the valve body for supporting the valve disc at the centerof the disc; at least one protrusion formed on the body for contactingthe disc in the open configuration; a retainer element positioned in thevalve on the opposite side of the disc from the support element, to holdthe center of the disc against the support element; and a valve elementreciprocally disposed in the fluid passageway of the valve on the sameside of the disc as the retainer element, the valve element beingmovable between a first position, wherein the valve element is distancedfrom the valve disc, and a second position, wherein the valve elementcontacts the valve disc to move the disc into its open configuration,wherein the valve element is moved to its second position when the luerfitting of the device is engaged with the luer fitting of the fluidsource.
 4. The drip chamber of claim 3, wherein the valve element is afemale valve element having a skirt and a head for engaging a male luerfitting.
 5. The device of claim 2, wherein the valve further comprises:asupport element positioned on the valve body for supporting the valvedisc at the center of the disc; at least one groove formed on the body;a retainer element positioned in the valve on the opposite side of thedisc from the support element, to hold the center of the disc againstthe support element; and a valve element reciprocally disposed in thefluid passageway of the valve on the same side of the disc as theretainer element, the valve element being movable between a firstposition, wherein the valve element is distanced from the valve disc,and a second position, wherein the valve element contacts the valve discto move the disc into its open configuration, wherein the valve elementis moved to its second position when the luer fitting of the device isengaged with the luer fitting of the fluid source.
 6. A drip chamber foruse with a source of fluid, comprising:an elongated transparentcontainer defining an elongated hollow chamber, the container having anopen proximal end, a distal end, and a drip-forming tube disposed in thechamber; and a female luer fitting attached to the container near thedistal end of the container, the fitting including: an annular femaleelement having a dull distal end and a passageway in fluid communicationwith the chamber, the passageway establishing the drip-forming tube, theelement being positioned with the dull distal end of the elementprotruding away from the distal end of the container, wherein fluid fromthe source of fluid can flow through the chamber from the distal end ofthe container through the open proximal end thereof, to thereby permitthe flow of the fluid from the distal end to the proximal end to bevisually monitored; and a valve disposed in the fluid passageway toselectively permit fluid flow therethrough, the valve having a closedconfiguration and an open configuration, the valve being biased to theclosed configuration and movable to the open configuration when thefitting is operably engaged with a complementary fitting, wherein thevalve includes: a hollow body defining a fluid passageway therethrough;a resilient valve disc positioned in the fluid passageway of the bodyand being biased into a closed configuration, wherein the disc blocksfluid flow through the fluid passageway, the disc being movable to anopen configuration, wherein fluid flow is permitted through the fluidpassageway; a support element positioned on the valve body forsupporting the valve disc at the center of the disc; at least oneprotrusion formed on the body for contacting the disc in the openconfiguration; a retainer element positioned in the valve on theopposite side of the disc from the support element, to hold the centerof the disc against the support element; and a valve elementreciprocally disposed in the fluid passageway of the valve on the sameside of the disc as the retainer element, the valve element beingmovable between a first position, wherein the valve element is distancedfrom the valve disc, and a second position, wherein the valve elementcontacts the valve disc to move the disc into its open configuration,wherein the valve element is moved to its second position when thefitting is engaged with a complementary fitting.
 7. The drip chamber ofclaim 1, wherein the valve element is a female valve element having askirt and a head for engaging a male luer fitting.